EP3419651C0 - Verbesserte naglu-fusionsproteinformulierung - Google Patents
Verbesserte naglu-fusionsproteinformulierungInfo
- Publication number
- EP3419651C0 EP3419651C0 EP17711041.8A EP17711041A EP3419651C0 EP 3419651 C0 EP3419651 C0 EP 3419651C0 EP 17711041 A EP17711041 A EP 17711041A EP 3419651 C0 EP3419651 C0 EP 3419651C0
- Authority
- EP
- European Patent Office
- Prior art keywords
- improved
- fusion protein
- protein formulation
- naglu fusion
- naglu
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 238000009472 formulation Methods 0.000 title 1
- 108020001507 fusion proteins Proteins 0.000 title 1
- 102000037865 fusion proteins Human genes 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/14—Hydrolases (3)
- C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
- C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
- A61K47/65—Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0085—Brain, e.g. brain implants; Spinal cord
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/575—Hormones
- C07K14/65—Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
- C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
- C12Y302/0105—Alpha-N-acetylglucosaminidase (3.2.1.50)
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Biomedical Technology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Genetics & Genomics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Wood Science & Technology (AREA)
- Immunology (AREA)
- Biophysics (AREA)
- Diabetes (AREA)
- General Engineering & Computer Science (AREA)
- Psychiatry (AREA)
- Hospice & Palliative Care (AREA)
- Endocrinology (AREA)
- Toxicology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Dermatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Psychology (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP23188800.9A EP4275751A3 (de) | 2016-02-24 | 2017-02-24 | Verbesserte naglu-fusionsproteinformulierung |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662299188P | 2016-02-24 | 2016-02-24 | |
| US201662428221P | 2016-11-30 | 2016-11-30 | |
| PCT/US2017/019343 WO2017147414A1 (en) | 2016-02-24 | 2017-02-24 | Targeted therapeutic lysosomal enzyme fusion proteins, associated formulations and uses thereof |
Related Child Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP23188800.9A Division EP4275751A3 (de) | 2016-02-24 | 2017-02-24 | Verbesserte naglu-fusionsproteinformulierung |
| EP23188800.9A Division-Into EP4275751A3 (de) | 2016-02-24 | 2017-02-24 | Verbesserte naglu-fusionsproteinformulierung |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| EP3419651A1 EP3419651A1 (de) | 2019-01-02 |
| EP3419651B1 EP3419651B1 (de) | 2023-10-25 |
| EP3419651C0 true EP3419651C0 (de) | 2023-10-25 |
Family
ID=58314512
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP17711041.8A Active EP3419651B1 (de) | 2016-02-24 | 2017-02-24 | Verbesserte naglu-fusionsproteinformulierung |
| EP23188800.9A Pending EP4275751A3 (de) | 2016-02-24 | 2017-02-24 | Verbesserte naglu-fusionsproteinformulierung |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP23188800.9A Pending EP4275751A3 (de) | 2016-02-24 | 2017-02-24 | Verbesserte naglu-fusionsproteinformulierung |
Country Status (14)
| Country | Link |
|---|---|
| US (3) | US11345904B2 (de) |
| EP (2) | EP3419651B1 (de) |
| JP (1) | JP7109369B2 (de) |
| KR (1) | KR20180114199A (de) |
| CN (1) | CN109069595A (de) |
| AU (1) | AU2017222620B2 (de) |
| BR (1) | BR112018017322A2 (de) |
| CA (1) | CA3015358A1 (de) |
| CL (1) | CL2018002430A1 (de) |
| IL (1) | IL261246B2 (de) |
| MX (1) | MX2018010196A (de) |
| RU (1) | RU2751235C2 (de) |
| WO (1) | WO2017147414A1 (de) |
| ZA (1) | ZA201805648B (de) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2017222620B2 (en) | 2016-02-24 | 2022-06-16 | Biomarin Pharmaceutical Inc. | Targeted therapeutic lysosomal enzyme fusion proteins, associated formulations and uses thereof |
| KR102471458B1 (ko) | 2016-12-28 | 2022-11-25 | 제이씨알 파마 가부시키가이샤 | 동결건조 제제 |
| CA3076369A1 (en) | 2017-10-02 | 2019-04-11 | Denali Therapeutics Inc. | Fusion proteins comprising enzyme replacement therapy enzymes |
| CN112566652A (zh) | 2018-06-25 | 2021-03-26 | Jcr制药股份有限公司 | 含有蛋白的水性液体制剂 |
| CN116916947A (zh) | 2020-10-14 | 2023-10-20 | 戴纳立制药公司 | 包含磺基葡糖胺磺基水解酶的融合蛋白和其方法 |
Family Cites Families (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6217552B1 (en) | 1999-03-01 | 2001-04-17 | Coaxia, Inc. | Medical device for selective intrathecal spinal cooling in aortic surgery and spinal trauma |
| US6537785B1 (en) | 1999-09-14 | 2003-03-25 | Genzyme Glycobiology Research Institute, Inc. | Methods of treating lysosomal storage diseases |
| US7629309B2 (en) | 2002-05-29 | 2009-12-08 | Zystor Therapeutics, Inc. | Targeted therapeutic proteins |
| EP1974752B1 (de) | 2001-04-30 | 2012-09-26 | BioMarin Pharmaceutical Inc. | Subzelluläres Targeting von therapeutischen Proteinen |
| US7560424B2 (en) | 2001-04-30 | 2009-07-14 | Zystor Therapeutics, Inc. | Targeted therapeutic proteins |
| US20040005309A1 (en) | 2002-05-29 | 2004-01-08 | Symbiontics, Inc. | Targeted therapeutic proteins |
| US20030072761A1 (en) | 2001-10-16 | 2003-04-17 | Lebowitz Jonathan | Methods and compositions for targeting proteins across the blood brain barrier |
| WO2003032727A1 (en) | 2001-10-16 | 2003-04-24 | Symbiontics Inc. | Methods and compositions for targeting underglycosylated proteins across the blood brain barrier |
| EP1514106A4 (de) | 2002-05-29 | 2007-05-09 | Zystor Therapeutics Inc | Gezielte therapeutische proteine |
| US7442372B2 (en) | 2003-08-29 | 2008-10-28 | Biomarin Pharmaceutical Inc. | Delivery of therapeutic compounds to the brain and other tissues |
| ATE465250T1 (de) | 2004-02-10 | 2010-05-15 | Zystor Therapeutics Inc | Saure alpha-glukosidase und fragmente davon |
| JO3000B1 (ar) * | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| PT2222315E (pt) | 2007-12-21 | 2013-07-16 | Cangene Corp | Formulações de fator ix estabilizadas contendo trealose |
| EP2279210B1 (de) | 2008-05-07 | 2017-04-12 | BioMarin Pharmaceutical Inc. | Auf lysosomen gerichtete peptide und ihre verwendung |
| ES2569514T3 (es) * | 2009-06-17 | 2016-05-11 | Biomarin Pharmaceutical Inc. | Formulaciones para enzimas lisosómicas |
| KR20120027031A (ko) | 2009-06-18 | 2012-03-20 | 와이어쓰 엘엘씨 | 소형 모듈 면역제약용 동결건조 제제 |
| NZ702801A (en) | 2010-06-25 | 2016-08-26 | Shire Human Genetic Therapies | Treatment of sanfilippo syndrome type b |
| NZ702808A (en) * | 2010-06-25 | 2016-08-26 | Shire Human Genetic Therapies | Methods and compositions for cns delivery of iduronate-2-sulfatase |
| PT3626257T (pt) * | 2010-06-25 | 2021-11-12 | Shire Human Genetic Therapies | Métodos e composições de arilsulfatase a para a administração no snc |
| RU2639521C2 (ru) * | 2011-05-05 | 2017-12-21 | ВЕЛЛСТАТ ИММЬЮНОТЕРАПЬЮТИКС, ЭлЭлСи | Аналоги фактора комплемента в и их применения |
| WO2013096899A2 (en) | 2011-12-23 | 2013-06-27 | Shire Human Genetic Therapies, Inc. | Stable formulations for cns delivery of arylsulfatase a |
| PL3115372T3 (pl) * | 2012-11-27 | 2019-09-30 | Biomarin Pharmaceutical Inc. | Ukierunkowane terapeutyczne fuzyjne białka enzymu lizosomalnego i ich zastosowania |
| AU2017222620B2 (en) | 2016-02-24 | 2022-06-16 | Biomarin Pharmaceutical Inc. | Targeted therapeutic lysosomal enzyme fusion proteins, associated formulations and uses thereof |
-
2017
- 2017-02-24 AU AU2017222620A patent/AU2017222620B2/en active Active
- 2017-02-24 RU RU2018132639A patent/RU2751235C2/ru active
- 2017-02-24 BR BR112018017322A patent/BR112018017322A2/pt unknown
- 2017-02-24 EP EP17711041.8A patent/EP3419651B1/de active Active
- 2017-02-24 EP EP23188800.9A patent/EP4275751A3/de active Pending
- 2017-02-24 CN CN201780025534.1A patent/CN109069595A/zh active Pending
- 2017-02-24 US US16/078,546 patent/US11345904B2/en active Active
- 2017-02-24 CA CA3015358A patent/CA3015358A1/en active Pending
- 2017-02-24 WO PCT/US2017/019343 patent/WO2017147414A1/en active Application Filing
- 2017-02-24 MX MX2018010196A patent/MX2018010196A/es unknown
- 2017-02-24 JP JP2018544940A patent/JP7109369B2/ja active Active
- 2017-02-24 IL IL261246A patent/IL261246B2/en unknown
- 2017-02-24 KR KR1020187027691A patent/KR20180114199A/ko not_active Application Discontinuation
-
2018
- 2018-08-23 ZA ZA2018/05648A patent/ZA201805648B/en unknown
- 2018-08-24 CL CL2018002430A patent/CL2018002430A1/es unknown
-
2022
- 2022-04-25 US US17/728,359 patent/US20220251526A1/en not_active Abandoned
-
2024
- 2024-03-19 US US18/609,855 patent/US20240263160A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| US20200297821A1 (en) | 2020-09-24 |
| CN109069595A (zh) | 2018-12-21 |
| MX2018010196A (es) | 2018-11-19 |
| JP2019506439A (ja) | 2019-03-07 |
| IL261246B2 (en) | 2023-03-01 |
| KR20180114199A (ko) | 2018-10-17 |
| IL261246B (en) | 2022-11-01 |
| EP4275751A2 (de) | 2023-11-15 |
| RU2018132639A3 (de) | 2020-07-15 |
| CL2018002430A1 (es) | 2018-12-28 |
| IL261246A (en) | 2018-10-31 |
| EP3419651B1 (de) | 2023-10-25 |
| BR112018017322A2 (pt) | 2019-01-02 |
| EP4275751A3 (de) | 2023-12-27 |
| US20240263160A1 (en) | 2024-08-08 |
| AU2017222620B2 (en) | 2022-06-16 |
| RU2751235C2 (ru) | 2021-07-12 |
| WO2017147414A1 (en) | 2017-08-31 |
| EP3419651A1 (de) | 2019-01-02 |
| ZA201805648B (en) | 2023-01-25 |
| US20220251526A1 (en) | 2022-08-11 |
| RU2018132639A (ru) | 2020-03-25 |
| CA3015358A1 (en) | 2017-08-31 |
| AU2017222620A1 (en) | 2018-09-06 |
| JP7109369B2 (ja) | 2022-07-29 |
| US11345904B2 (en) | 2022-05-31 |
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